510(k) K901377
K901377 is an FDA 510(k) premarket notification submitted by Medical Innovations International, Inc. for the device "BARTON-MAYO TRACHEOSTOMA BUTTON". The FDA issued a decision of Substantially Equivalent on June 14, 1990. The device falls under product code KAC (Tube, Laryngectomy), a Class I device regulated under 21 CFR 874.4420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1990
- Date Received
- March 22, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Laryngectomy
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type